(19 days)
The Vilex/DuVal Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but not limited to. Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery.
The materials manufacture this screw are 316L, implant-quality used to stainloss steel and Ti6Al4V, implant-quality titanium. When properly with Vilex instrumentation, used this screw safe purchase and compression for cortical and achieves cancellous bone fixation in the human body.
This document is a 510(k) clearance letter from the FDA for a medical device called the "Vilex/DuVal Cannulated Bone Screw." It approves the device for marketing based on its substantial equivalence to a legally marketed predicate device.
Unfortunately, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The letter is a regulatory clearance document, not a technical report detailing performance testing or clinical studies.
Specifically, the following information is not found in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not list any specific performance criteria (e.g., tensile strength, fatigue life, torque resistance) or the results of tests against such criteria.
- Sample size used for the test set and the data provenance: No information about a test set, its size, or the origin of data is present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is described, no information about experts or ground truth establishment is available.
- Adjudication method for the test set: Not applicable as no test set is discussed.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This type of study is typically for diagnostic imaging devices involving human readers. A cannulated bone screw is an implantable surgical device, making such a study highly improbable and certainly not mentioned here.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This pertains to AI algorithms. The device in question is a physical bone screw, not an AI product.
- The type of ground truth used: No ground truth is discussed.
- The sample size for the training set: Not applicable, as this is not an AI or diagnostic imaging device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The letter primarily focuses on:
- Confirming the FDA's receipt and review of the 510(k) notification.
- Stating the substantial equivalence of the "Vilex/DuVal Cannulated Bone Screw" to pre-amendments devices or reclassified devices.
- Listing the "Indications for Use" for the device (Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment in various surgical fields).
- Specifying the materials used (316L stainless steel and Ti6Al4V titanium).
- Mentioning that the screw, when properly used with Vilex instrumentation, "achieves safe purchase and compression for cortical and cancellous bone fixation." This statement is a claim of intended function, not a quantified performance result from a specific study.
- Outlining regulatory responsibilities for the manufacturer.
To obtain the information requested, one would need to review the actual 510(k) submission (K991151 and K991197), which would contain the technical data, test reports, and details of any studies conducted to demonstrate substantial equivalence and device performance. The FDA clearance letter itself only summarizes the outcome of that review.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.